(Silver Spring, MD, June 21, 2006) -- A press conference was held in the U.S. Capitol today to announce the introduction of legislation that will require companies that sell dietary supplements and over-the-counter drugs to submit serious adverse event reports that they receive from their customers to the Food and Drug Administration.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, supported by Senators Orrin Hatch (R-UT), Richard Durbin (D-IL) and Tom Harkin (D-IA), will require companies to include on their products’ labels an address or phone number through which consumers can report adverse events that they associate with their use of a supplement or OTC drug. Companies will be obliged to inform FDA of any serious adverse event reports they receive within 15 business days.
“The Board of the American Herbal Products Association adopted a position in October 2002 calling for a regulatory change to mandate that serious adverse event reports associated with supplements be forwarded to FDA,” commented Michael McGuffin, AHPA president. “AHPA communicated its decision to Senators Hatch, Durbin and Harkin at that time, and has worked closely with their offices to reach this important goal.”
The legislation as introduced will also assure the companies that file reports that any submission they make to FDA will not constitute an admission that their products caused or contributed to the reported event, and that the privacy of individuals will be protected to prevent any misuse of the system.
“Dietary supplements as a class have a remarkable safety record,” added McGuffin. “The many Americans who use them responsibly can continue to exercise their freedom of choice, knowing that the rare problems that might be reported will generate the signals that are needed to inform FDA. And marketers of these products can be certain that they will be provided with the same kinds of protection that the pharmaceutical industry enjoys, so that this system does not penalize companies that comply.”
Several other trade groups that represent manufacturers of dietary supplements and OTC drugs have also expressed their support of this legislation. “AHPA is pleased that so many of our colleagues have joined us to move this bill forward,” added McGuffin.
The bill has been assigned a number: S. 3546. AHPA will provide a link to the text of the bill when it is available.
The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.